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临床试验/NCT01474759
NCT01474759已完成不适用

Portion Size Strategies for Management of Body Weight

Penn State University2 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
186
试验地点
2
主要终点
Change in body weight

研究概览

简要总结

The primary aim of this research is to determine the efficacy of two portion-control strategies to achieve sustainable dietary and behavior changes and to promote weight loss and maintenance. A randomized controlled trial will test two approaches to managing portion sizes: one that gives individuals skills and tools to help them make appropriate portion choices, and another that focuses on consumption of pre-portioned foods in order to limit exposure to large portions in the personal food environment. A third group will receive a basic nutritional program to promote weight loss.

The second aim of the research is to determine the effects of the programs on knowledge and consumption of appropriate portions, as assessed by innovative assessment methods and multiple-pass dietary recalls. The third aim is to conduct exploratory analyses of individual factors that may influence the response to the portion-control interventions, such as psychosocial indicators, blood biomarkers, and measures of adherence to the interventions. The expected outcome of the project is that it will lead to the development of specific, evidence-based strategies to help control portion sizes in order to manage weight.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Body mass index of 28 to 45 kg/m squared
  • Able to safely engage in physical activity (walking)
  • Able to attend regular instructional sessions at University Park, Pennsylvania

排除标准

  • have a medical condition diagnosed by a physician that precludes participation
  • report symptoms indicative of depression or disordered eating
  • report serious food allergies or intolerance
  • current or planned participation in a weight-loss program
  • pregnant or lactating or planning to become pregnant in the next 18 months

结局指标

主要结局

Change in body weight

时间窗: Months 0 to 12

Body weight will be measured at multiple time points during the 12-month trial; the main outcome will be the weight trajectory across this time

次要结局

  • Change in waist circumference(Months 0, 3, 6, & 12)
  • Change in portion size selection, perception, and knowledge(Months 0, 3, 6, & 12)
  • Change in portion size consumption(Months 0, 3, 6, & 12)
  • Change in blood biomarkers(Months 0, 3, 6, & 12)
  • Change in blood pressure(Months 0, 3, 6, & 12)
  • Change in dietary intakes(Months 0, 3, 6, 9, & 12)
  • Change in step counts(Months 0, 3, 6, 9, & 12)
  • Change in attitudes and behaviors related to food and eating(Months 0, 1, 3, 6, & 12)
  • Change in psychosocial characteristics(Months 0, 3, 6, & 12)
  • Intervention adherence(Month 12)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Barbara J. Rolls

Principal Investigator

Penn State University

研究点 (2)

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